OBREDON

Product NDC: 58716-433
11-digit product format: 587160433
Labeler code: 58716
Product ID: 58716-433_eea155aa-d164-2b48-e053-2995a90a8127
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocodone Bitartrate and Guaifenesin
Dosage form: SOLUTION
Route: ORAL
Labeler: Sovereign Pharmaceuticals, LLC
Application: NDA205474
Marketing category: NDA
Marketing start: 2014-12-30
Marketing end: 0000-00-00
Substance: GUAIFENESIN; HYDROCODONE BITARTRATE
Active strength: 200 mg/5mL; mg/5mL
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	58716-433		D	Discontinued by firm	2026-08-11
excluded package	package	58716-433	58716-433-04	D	Discontinued by firm	2026-08-11
excluded package	package	58716-433	58716-433-16	D	Discontinued by firm	2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product	58716-433		I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	58716-433	58716-433-16	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	58716-433	58716-433-04	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N205474-001	OBREDON	GUAIFENESIN; HYDROCODONE BITARTRATE	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL		RLD	2014-11-14

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16
N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30
N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
53523715-c529-4d52-b9ff-1e5d76636f53	Product name	2	20210818
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
31b11e56-5b35-4ab6-a3a8-f0b48973dced	Product name	2	20200611
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
7855f8e3-562e-4273-8b79-0059c07a71f7	Product name	1	20170901
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
a5244f9c-cd67-0e27-d63b-65fd7e584400	Product name	2	20170504
b654f2d9-ebeb-451d-96ee-22f583344623	Product name	1	20170424
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
58716-433-04	2020-11-17	These highlights do not include all the information needed to use OBREDON ® safely and effectively. See full prescribing information for OBREDON. OBREDON (hydrocodone bitartrate and guaifenesin) oral solution CII Initial U.S. Approval: 2014
58716-433-04	2020-11-17	These highlights do not include all the information needed to use OBREDON ® safely and effectively. See full prescribing information for OBREDON. OBREDON (hydrocodone bitartrate and guaifenesin) oral solution CII Initial U.S. Approval: 2014
58716-433-16	2020-11-17	These highlights do not include all the information needed to use OBREDON ® safely and effectively. See full prescribing information for OBREDON. OBREDON (hydrocodone bitartrate and guaifenesin) oral solution CII Initial U.S. Approval: 2014
58716-433-16	2020-11-17	These highlights do not include all the information needed to use OBREDON ® safely and effectively. See full prescribing information for OBREDON. OBREDON (hydrocodone bitartrate and guaifenesin) oral solution CII Initial U.S. Approval: 2014
58716-433-04	2020-01-31	These highlights do not include all the information needed to use OBREDON ® safely and effectively. See full prescribing information for OBREDON. OBREDON (hydrocodone bitartrate and guaifenesin) oral solution CII Initial U.S. Approval: 2014
58716-433-04	2020-01-31	These highlights do not include all the information needed to use OBREDON ® safely and effectively. See full prescribing information for OBREDON. OBREDON (hydrocodone bitartrate and guaifenesin) oral solution CII Initial U.S. Approval: 2014
58716-433-16	2020-01-31	These highlights do not include all the information needed to use OBREDON ® safely and effectively. See full prescribing information for OBREDON. OBREDON (hydrocodone bitartrate and guaifenesin) oral solution CII Initial U.S. Approval: 2014
58716-433-16	2020-01-31	These highlights do not include all the information needed to use OBREDON ® safely and effectively. See full prescribing information for OBREDON. OBREDON (hydrocodone bitartrate and guaifenesin) oral solution CII Initial U.S. Approval: 2014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58716-433	OBREDON (HYDROCODONE BITARTRATE AND GUAIFENESIN) SOLUTION [SOVEREIGN PHARMACEUTICALS, LLC]	9	Legacy NDC	20241017_f73fdec5-d330-4d8c-894b-d0bcf5490624.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
NO70W886KK	HYDROCODONE BITARTRATE	34195-34-1	HYDROCODONE BITARTRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58716-433-04	58716043304	118 mL in 1 BOTTLE (58716-433-04)	118 ml	2014-12-30	0000-00-00	No	No	Current
58716-433-16	58716043316	473 mL in 1 BOTTLE (58716-433-16)	473 ml	2014-12-30	0000-00-00	No	No	Current